NovoKnee Total Knee System 3420-5010

GUDID 00811382037283

Patellar Drill & Cement Clamp

NOVOSOURCE, LLC

Joint prosthesis implantation kit, reusable

• Primary Device ID: 00811382037283
• NIH Device Record Key: 1d0e5d69-c193-45b4-a40e-357233b23576
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovoKnee Total Knee System
• Version Model Number: 3420-5010
• Catalog Number: 3420-5010
• Company DUNS: 081034828
• Company Name: NOVOSOURCE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811382037283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123339

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00811382037283]

Moist Heat or Steam Sterilization

[00811382037283]

Moist Heat or Steam Sterilization

[00811382037283]

Moist Heat or Steam Sterilization

[00811382037283]

Moist Heat or Steam Sterilization

[00811382037283]

Moist Heat or Steam Sterilization

[00811382037283]

Moist Heat or Steam Sterilization

[00811382037283]

Moist Heat or Steam Sterilization

[00811382037283]

Moist Heat or Steam Sterilization

[00811382037283]

Moist Heat or Steam Sterilization

[00811382037283]

Moist Heat or Steam Sterilization

[00811382037283]

Moist Heat or Steam Sterilization

[00811382037283]

Moist Heat or Steam Sterilization

[00811382037283]

Moist Heat or Steam Sterilization

[00811382037283]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-27
• Device Publish Date: 2019-09-19

On-Brand Devices [NovoKnee Total Knee System]

• 00811382037047: NK Knee Case 3 CR
• 00811382037030: NK Knee Case 2 CR
• 00811382037009: NK Knee Case 2
• 00811382036996: NK Knee Case 1
• 00811382036989: NK Knee Case 3
• 00811382036972: Patellar Resection Clamp Foot
• 00811382036965: Vernier Caliper
• 00811382036903: Patellar Drill Guide
• 00811382036873: Patella 38mm Trial
• 00811382036866: Patella 35mm Trial
• 00811382036859: Patella 32mm Trial
• 00811382036842: Patella 29mm Trial
• 00811382036811: UC Tibial Insert Size 6 18mm Trial
• 00811382036804: UC Tibial Insert Size 5 18mm Trial
• 00811382036798: UC Tibial Insert Size 4 18mm Trial
• 00811382036781: UC Tibial Insert Size 3 18mm Trial
• 00811382036774: UC Tibial Insert Size 2 18mm Trial
• 00811382036767: UC Tibial Insert Size 1 18mm Trial
• 00811382036750: UC Tibial Insert Size 6 15mm Trial
• 00811382036743: UC Tibial Insert Size 5 15mm Trial
• 00811382036736: UC Tibial Insert Size 4 15mm Trial
• 00811382036729: UC Tibial Insert Size 3 15mm Trial
• 00811382036712: UC Tibial Insert Size 2 15mm Trial
• 00811382036705: UC Tibial Insert Size 1 15mm Trial
• 00811382036699: UC Tibial Insert Size 6 13mm Trial
• 00811382036682: UC Tibial Insert Size 5 13mm Trial
• 00811382036675: UC Tibial Insert Size 4 13mm Trial
• 00811382036668: UC Tibial Insert Size 3 13mm Trial
• 00811382036651: UC Tibial Insert Size 2 13mm Trial
• 00811382036644: UC Tibial Insert Size 1 13mm Trial
• 00811382036637: UC Tibial Insert Size 6 11mm Trial
• 00811382036620: UC Tibial Insert Size 5 11mm Trial
• 00811382036613: UC Tibial Insert Size 4 11mm Trial
• 00811382036606: UC Tibial Insert Size 3 11mm Trial
• 00811382036590: UC Tibial Insert Size 2 11mm Trial
• 00811382036583: UC Tibial Insert Size 1 11mm Trial
• 00811382036576: UC Tibial Insert Size 6 9mm Trial
• 00811382036569: UC Tibial Insert Size 5 9mm Trial
• 00811382036552: UC Tibial Insert Size 4 9mm Trial
• 00811382036545: UC Tibial Insert Size 3 9mm Trial
• 00811382036538: UC Tibial Insert Size 2 9mm Trial
• 00811382036521: UC Tibial Insert Size 1 9mm Trial
• 00811382036514: HC PS Tibial Insert Size 6 18mm Trial
• 00811382036507: HC PS Tibial Insert Size 5 18mm Trial
• 00811382036491: HC PS Tibial Insert Size 4 18mm Trial
• 00811382036484: HC PS Tibial Insert Size 3 18mm Trial
• 00811382036477: HC PS Tibial Insert Size 2 18mm Trial
• 00811382036460: HC PS Tibial Insert Size 1 18mm Trial
• 00811382036453: HC PS Tibial Insert Size 6 15mm Trial
• 00811382036446: HC PS Tibial Insert Size 5 15mm Trial